Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-100
SponsorUniversity of Florida

About this trial

Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English speaking patients

55 years or older with Su Type II or Su Type III periprosthetic femur fractures or OTA/OA 33C or 338/3 native knee distal femur fracturing requiring surgical intervention and are medically fit to undergo surgical intervention

Disqualifiers

Patients with an active total knee prosthetic infection

Patients unable to undergo surgical intervention

Patient with an open fracture

Non-English-speaking patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Timed Up and Go Test on subjects with ORIF of distal femur fractures

    Other intervention

    Subjects will perform the Timed Up and Go Test This test is used to assess mobility. Subjects are asked to wear regular footwear and can use their walking device as needed. Subjects begin by sitting in a standard armchair. Next participants are instructed to walk 10 feet to a designated line at a normal pace. Once they reach the line they are to turn and walk back to the chair and sit down. The test starts on the study staff go signal and ends once the subject is fully seated in the chair. Test will be performed at 6 weeks, 3 months, 6 months, 12 months and 24 months post surgical treatment.

  • Koos Jr assesment on subjects with ORIF of distal femur fractures

    Other intervention

    Subjects will complete the KOOS Jr assessment. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.

  • Timed Up and Go Test on subjects with DFR of distal femur fracture

    Other intervention

    Subjects will perform the Timed Up and Go Test This test is used to assess mobility. Subjects are asked to wear regular footwear and can use their walking device as needed. Subjects begin by sitting in a standard armchair. Next participants are instructed to walk 10 feet to a designated line at a normal pace. Once they reach the line they are to turn and walk back to the chair and sit down. The test starts on the study staff go signal and ends once the subject is fully seated in the chair. Test will be performed at 6 weeks, 3 months, 6 months, 12 months and 24 months post surgical treatment.

  • Koos Jr assesment on subjects with DFR of distal femur fracture

    Other intervention

    Subjects will complete the KOOS Jr assessment. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Open reduction and internal fixation (ORIF) of distal femur fractureActive comparator 2 interventions
Group B: Distal femur replacement total knee arthroplasty (DFR) of distal femur fractureActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Open reduction and internal fixation (ORIF) of distal femur fracture

Subjects will perform the Timed Up and Go Test, This test is used to assess mobility. Subjects are asked to wear regular footwear and can use their walking device as needed. Subjects begin by sitting in a standard armchair. Next participants are instructed to walk 10 feet to a designated line at a normal pace. Once they reach the line they are to turn and walk back to the chair and sit down. The test starts on the study staff go signal and ends once the subject is fully seated in the chair.

Time frame
Up to 2 years

Secondary outcomes

1

Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture

Subjects will complete the KOOS Jr assessment. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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